Iron Deficiency Anemia of PregnancyPhase 4NCT03188445
Intravenous Iron Isomaltoside Versus Oral Iron Supplementation for Treatment of Iron Deficiency in Pregnancy.
A Phase 4 study testing Iron Isomaltoside 1000 and ferrous fumarate with ascorbic acid in people with Iron Deficiency Anemia of Pregnancy, run by Pharmacosmos A/S at 1 site in Denmark.
Trial summary
Intravenous iron isomaltoside versus oral iron supplementation for treatment of iron deficiency in pregnancy Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Iron Deficiency Anemia of Pregnancy
- What is being tested?
- Iron Isomaltoside 1000 and ferrous fumarate with ascorbic acid
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 201 participants
- Where
- 1 siteDenmark
- Study dates
- 11 Jul 2017to 18 Aug 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women aged ≥18 years
- Pregnancy at GA 14+0 - 19+0
- Ferritin <30 μg/L after 4 weeks of standard treatment in a clinical setting
- Willingness to participate and attend all planned follow-up visits, and signing the in-formed consent form
Who cannot join
- History of anaemia caused by e.g. thalassemia, hypersplenism or haemolytic anaemia (known haematologic disorder other than iron deficiency)
- Iron overload or disturbances in utilisation of iron (e.g. haemochromatosis and haemosiderosis)
- Drug hypersensitivity (i.e. previous hypersensitivity to IV iron)
- Known hypersensitivity to any excipients in the investigational drug products
- History of active asthma within the last 5 years
- History of multiple allergies
Show all 16Show fewer
- Known decompensated liver cirrhosis or active hepatitis
- Active acute or chronic infections (assessed by clinical judgement)
- Rheumatoid arthritis with symptoms or signs of active inflammation
- Treated with IV iron products or blood transfusion within 4 weeks prior to inclusion
- Treated with erythropoietin (EPO) within 4 weeks prior to inclusion
- Participation in any other interventional trial where the trial drug has not passed 5 half-lives prior to inclusion
- Any other medical condition that, in the opinion of the Investigator, may cause the subject to be unsuitable for the completion of the trial or place the subject at potential risk from being in the trial
- Meeting RBC-transfusion criteria (Hb ≤6.9 g/dL= 4.3 mmol/L with intolerable symptoms of anaemia like severe palpitations, severe dizziness, shortness of breath at rest or syncope or an Hb ≤6.4 g/dL (4.0 mmol/L) without intolerable symptoms of anaemia)
- Multiple pregnancies
- Inability to read and understand the Danish language
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intravenous Iron Isomaltoside Versus Oral Iron Supplementation for Treatment of Iron Deficiency in Pregnancy: a Randomised, Comparative, Open-label Trial
Intravenous iron isomaltoside versus oral iron supplementation for treatment of iron deficiency in pregnancy
Read the detailed description
Iron deficiency (ID) in pregnant women can cause iron deficiency anaemia (IDA). ID is defined by low iron stores, measured by a low level of s-ferritin. Iron is essential for the synthesis of haemoglobin (Hb). Anaemia is defined by a low Hb level (<11.0 g/dL in 1st trimester, <10.5 g/dL in 2nd, and <10.5 - 11.0 g/dL in 3rd trimesters).
In Danish pregnant women, who do not take iron supplementation approximately 50 % have ID and 21 % have IDA. According to WHO anaemia, defined as Hb <11.0 g/dL, regardless the cause is estimated to occur in 24 % of Danish pregnant women.
This trial is designed to evaluate and compare the effect of IV iron isomaltoside to a fixed dose of oral iron administered as tablet ferrous fumarate with ascorbic acid as correction of IDA in pregnant women after 4 weeks of standard treatment.
- Conditions
- Iron Deficiency Anemia of Pregnancy
- Being tested
- Iron Isomaltoside 1000, ferrous fumarate with ascorbic acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron Isomaltoside 1000Drug
Administered iv
ferrous fumarate with ascorbic acidDrug
Oral administration
| Study group | Role | What they receive |
|---|---|---|
| IV administration | Experimental | Iron isomaltoside (Monofer) Administered iv Receives: Drug: Iron Isomaltoside 1000 |
| Oral administration | Active comparator | Ferrous fumarate with ascorbic acid Administered oral Receives: Drug: ferrous fumarate with ascorbic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure is the achievement of an hemoglobin equal or above 11 g/dL
Measured: from baseline to 18 weeks after treatment
Secondary outcomes (2)
Achievement of an hemoglobin equal to or above 11 g/dL
Measured: T=3 weeks, T=6 weeks, T=12 weeks, and T=18 weeks
Change in iron biomarkers
Measured: From baseline to T=3 weeks, T=6 weeks, T=12 weeks, and T=18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2017
- Study start11 Jul 2017
- Primary completion26 Jun 2020
- Study completion18 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Iron Deficiency Anemia of PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pharmacosmos A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pharmacosmos A/S Clinical and Non-clinical Research, Study director, Pharmacosmos A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03188445
- Sponsor's protocol ID
- P-Monofer-PREG-01
- Status last verified
- Oct 2020
- First submitted
- 13 Jun 2017
- Last updated
- 13 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hansen R, Sommer VM, Pinborg A, Krebs L, Thomsen LL, Moos T, Holm C. Intravenous ferric derisomaltose versus oral iron for persistent iron deficient pregnant women: a randomised controlled trial. Arch Gynecol Obstet. 2023 Oct;308(4):1165-1173. doi: 10.1007/s00404-022-06768-x. Epub 2022 Sep 15.
PubMed 36107229Markova V, Hansen R, Thomsen LL, Pinborg A, Moos T, Holm C. Intravenous iron isomaltoside versus oral iron supplementation for treatment of iron deficiency in pregnancy: protocol for a randomised, comparative, open-label trial. Trials. 2020 Aug 26;21(1):742. doi: 10.1186/s13063-020-04637-z.
PubMed 32843079
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Iron Isomaltoside Versus Oral Iron Supplementation for Treatment of Iron Deficiency in Pregnancy: a Randomised, Comparative, Open-label Trial
- ClinicalTrials.gov ID
- NCT03188445
- Acronym / sponsor ID
- P-Monofer-PREG-01
- Conditions
- Iron Deficiency Anemia of Pregnancy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Pharmacosmos A/SIndustry (pharma, biotech, devices)
- Study start
- 11 Jul 2017 (actual)
- Primary completion
- 26 Jun 2020 (actual)
- Study completion
- 18 Aug 2020 (actual)
- First posted
- 15 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Intravenous iron isomaltoside versus oral iron supplementation for treatment of iron deficiency in pregnancy
Detailed description
Iron deficiency (ID) in pregnant women can cause iron deficiency anaemia (IDA). ID is defined by low iron stores, measured by a low level of s-ferritin. Iron is essential for the synthesis of haemoglobin (Hb). Anaemia is defined by a low Hb level (<11.0 g/dL in 1st trimester, <10.5 g/dL in 2nd, and <10.5 - 11.0 g/dL in 3rd trimesters).
In Danish pregnant women, who do not take iron supplementation approximately 50 % have ID and 21 % have IDA. According to WHO anaemia, defined as Hb <11.0 g/dL, regardless the cause is estimated to occur in 24 % of Danish pregnant women.
This trial is designed to evaluate and compare the effect of IV iron isomaltoside to a fixed dose of oral iron administered as tablet ferrous fumarate with ascorbic acid as correction of IDA in pregnant women after 4 weeks of standard treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IV administration | Experimental | Drug: Iron Isomaltoside 1000Iron isomaltoside (Monofer) Administered iv |
| Oral administration | Active comparator | Drug: ferrous fumarate with ascorbic acidFerrous fumarate with ascorbic acid Administered oral |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women aged ≥18 years
- Pregnancy at GA 14+0 - 19+0
- Ferritin <30 μg/L after 4 weeks of standard treatment in a clinical setting
- Willingness to participate and attend all planned follow-up visits, and signing the in-formed consent form
Key exclusion criteria (16 listed)
- History of anaemia caused by e.g. thalassemia, hypersplenism or haemolytic anaemia (known haematologic disorder other than iron deficiency)
- Iron overload or disturbances in utilisation of iron (e.g. haemochromatosis and haemosiderosis)
- Drug hypersensitivity (i.e. previous hypersensitivity to IV iron)
- Known hypersensitivity to any excipients in the investigational drug products
- History of active asthma within the last 5 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iron Isomaltoside 1000Administered iv | Drug | IV administration |
| ferrous fumarate with ascorbic acidOral administration | Drug | Oral administration |
Primary outcome
The primary outcome measure is the achievement of an hemoglobin equal or above 11 g/dL
Time frame: from baseline to 18 weeks after treatment
2 secondary outcomes
Achievement of an hemoglobin equal to or above 11 g/dL
Time frame: T=3 weeks, T=6 weeks, T=12 weeks, and T=18 weeks
Change in iron biomarkers
Time frame: From baseline to T=3 weeks, T=6 weeks, T=12 weeks, and T=18 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2020.
- Derived from this study: PubMed 36107229Hansen R, Sommer VM, Pinborg A, Krebs L, Thomsen LL, Moos T, Holm C. Intravenous ferric derisomaltose versus oral iron for persistent iron deficient pregnant women: a randomised controlled trial. Arch Gynecol Obstet. 2023 Oct;308(4):1165-1173. doi: 10.1007/s00404-022-06768-x. Epub 2022 Sep 15.
- Derived from this study: PubMed 32843079Markova V, Hansen R, Thomsen LL, Pinborg A, Moos T, Holm C. Intravenous iron isomaltoside versus oral iron supplementation for treatment of iron deficiency in pregnancy: protocol for a randomised, comparative, open-label trial. Trials. 2020 Aug 26;21(1):742. doi: 10.1186/s13063-020-04637-z.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pharmacosmos A/S Clinical and Non-clinical Research study director
Pharmacosmos A/S
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Iron Isomaltoside 1000 and ferrous fumarate with ascorbic acid in people with Iron Deficiency Anemia of Pregnancy, run by Pharmacosmos A/S at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome measure is the achievement of an hemoglobin equal or above 11 g/dL (time frame: from baseline to 18 weeks after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03188445, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2020.